Use of Azithromycin and Rifabutin Administered 3 Times Weekly for the Treatment of M. Avium Complex (MAC) Lung Disease

NCT00598962 | Completed Phase 4

• 1 other identifier: 426
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the safety and efficacy of azithromycin, rifabutin and ethambutol given three times weekly in the treatment of lung infection with M. avium complex(MAC)

Conditions

Mycobacterium Avium Complex

Keywords

MAC

Outcome Measures

Primary Outcomes (1)

• Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures

  neg cultures X3 ( sputum conversion)

  6 months

Secondary Outcomes (1)

• Microbiological cultures

  1yr

Study Arms (1)

azithromycin and rifabutin/rifampin

EXPERIMENTAL

Azithromycin and rifabutin/rifampin administered three times weekly.

Drug: Azithromycin; Drug: Rifabutin/rifampin

Interventions

Azithromycin DRUG

Dosage dependent on clinical factors such as age, weight and patient-specific health status

Also known as: Zithromax

azithromycin and rifabutin/rifampin

Rifabutin/rifampin DRUG

Also known as: mycobutin/

azithromycin and rifabutin/rifampin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet American Thoracic Society criteria for nontuberculous lung disease: two or more AFB smear positive, culture positive sputums or bronchoscopic samples and/or two or more AFB smear negative respiratory samples with moderate to heavy growth (2+-4+); abnormal CXR consistent with M. avium lung disease; abnormal CXR consistent with M. avium lung disease; absence of other lung pathogens (except for the coexistence of M. abscessus).
• Age 18 and older
• Pretreatment isolate of M. avium complex available for MIC determination
• Baseline laboratory and clinical testing for baseline CBC, Chemistry (including liver enzymes), hearing test, visual acuity and color discrimination
• Available for long term followup

You may not qualify if:

• History of macrolide or rifamycins allergy
• Laboratory evidence of mycobacterial resistance to azithromycin
• Children less than 18 years of age
• If a menstruating female, not pregnant and on adequate birth control
• HIV+ or at risk

Sponsors & Collaborators

• The University of Texas Health Science Center at Tyler: lead
• Pfizer: collaborator

Study Sites (1)

The University of Texas Health Science Center at Tyler

Tyler, Texas, 75708, United States

Location

MeSH Terms

Conditions

Mycobacterium avium-intracellulare Infection

Interventions

Azithromycin; Rifabutin; Rifampin

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Richard J Wallace Jr., M.D.

  The University of Texas Health Science Center at Tyler

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman Department of Microbiology

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: January 23, 2008
• Study Start: December 1, 1994
• Primary Completion: November 1, 2006
• Study Completion: May 18, 2017
• Last Updated: May 23, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)